Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database (09-SQOL)
This study is ongoing, but not recruiting participants.
Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01353677
First received: May 12, 2011
Last updated: April 3, 2014
Last verified: April 2014
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Purpose
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.
| Condition |
|---|
|
Hematopoietic Stem Cell Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database |
Further study details as provided by Center for International Blood and Marrow Transplant Research:
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| HSCT recipients |
Detailed Description:
QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Pediatric and adult allogeneic HCT recipients
Criteria
Inclusion Criteria:
- Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
- Signed informed consent form from adult patient or parent/guardian of pediatric patient.
- Patient must have a valid mailing address within the United States to receive QOL surveys.
- Ability to speak and read English.
- Patients with access to a telephone.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353677
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353677
Locations
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Medical College of Wisconsin
Investigators
| Principal Investigator: | Douglas Rizzo, MD, MS | CIBMTR/ Medical College of Wisconsin |
More Information
No publications provided
| Responsible Party: | Center for International Blood and Marrow Transplant Research |
| ClinicalTrials.gov Identifier: | NCT01353677 History of Changes |
| Other Study ID Numbers: | 09-SQOL |
| Study First Received: | May 12, 2011 |
| Last Updated: | April 3, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Center for International Blood and Marrow Transplant Research:
|
Hematopoietic stem cell transplantation QOL |
ClinicalTrials.gov processed this record on March 01, 2015